📋 FDA Reference
Arrow Seldinger Arterial Catherization Devices Models Ex Sac 00520
Arrow Intl.
Summary: The Arrow Seldinger Arterial Catheterization Devices are used for arterial access, primarily in critical care and surgical settings. They are typically used by anesthesiologists, intensivists, and surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K093050 ↗
Decision Date ?
December 18, 2009
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The device was cleared through the FDA 510(k) pathway on December 18, 2009. Manufactured by Arrow Intl., it is classified as a Class 2 device under product code DQY.
What It Is
The Arrow Seldinger Arterial Catheterization Devices are designed for arterial access using the Seldinger technique, which involves inserting a catheter over a guidewire. This method is commonly used to obtain arterial blood samples, monitor blood pressure, and administer medications directly into the arterial system.
FDA-Cleared Indications
- Percutaneous catheterization of an artery using the Seldinger technique.
- Arterial access for continuous blood pressure monitoring.
- Arterial access for obtaining blood samples, including arterial blood gas samples.
- Arterial access for administration of medications or fluids when clinically indicated by the labeling.
Clinical Applications
- Placement of an arterial catheter in critical care patients who require continuous hemodynamic monitoring.
- Arterial catheterization during surgery or anesthesia for blood pressure monitoring.
- Repeated arterial blood sampling, including arterial blood gas analysis.
- Percutaneous arterial access in emergency and intensive-care settings.
Practical Considerations
- The devices are available in different catheter sizes and configurations; selection depends on the artery, patient size, duration of monitoring, and clinical purpose.
- Placement requires sterile technique, local anesthesia or procedural sedation when appropriate, and familiarity with guidewire-based Seldinger access.
- The catheter must be connected to compatible pressure-monitoring tubing and transducer equipment when used for arterial pressure monitoring.
- Potential complications include bleeding, hematoma, thrombosis, distal ischemia, infection, arterial spasm, and accidental arterial injury.
- MRI safety depends on the specific catheter, guidewire, and any attached components; the product labeling and institutional MRI policy should be checked before scanning.
Frequently Asked Questions
What is the Arrow Seldinger Arterial Catheterization Device used for?
It is used for arterial access to monitor blood pressure, obtain blood samples, and administer medications.
What specialties typically use this device?
Anesthesiologists, intensivists, and surgeons commonly use this device in critical care and surgical settings.
What are the FDA-cleared indications?
The device is indicated for arterial access in patients requiring monitoring, blood sampling, or medication administration.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.